Former Pfizer Exec Criticizes Cruz Drug Approval Bill
Former Pfizer executive John LaMattina says that legislation introduced last year by Sen. Ted Cruz (R-TX) to change how FDA approves drugs would actually likely hurt the drug industry. Writing in a Forbes online opinion column, LaMattina says that Cruz’ Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act would allow for reciprocal approval of drugs, medical devices, and biologics from foreign sponsors in European countries and Japan, Canada, Australia, and Israel. The bill also would allow Congress to overrule FDA rejections of life-saving drugs with a majority vote on a joint resolution.
“Reducing FDA’s authority will undoubtedly relax approval standards to the lowest common denominator,” the column says. “Eventually this will come back to haunt both patients and drug makers. All drugs have side effects, and FDA’s approval process helps to put into perspective the benefit-risk profile of new medicines. Giving Congress the right to overrule FDA approval decisions would make the process more political than scientific. Such a move would eventually penalize companies like Pfizer, Merck, and GlaxoSmithKline who would be blamed for producing unsafe medicines — medicines approved by legislators.”
LaMattina says Cruz claimed that his bill would “unleash life-saving drugs and devices in the United States, help mitigate critical drug shortages…, and put downward pressure on the price of medical devices and drugs as well.”
Based on that justification, he writes, one could think that FDA is lagging the rest of the world with respect to the approval of new drugs and the time the agency takes to approve new breakthroughs. “Actually, that isn’t the case,” LaMattina declares. He cites a 2010 article in the New England Journal of Medicine that reviewed novel drugs approved between 2001 and 2010 and found that “FDA has provided more and rapid reviews of applications involving novel therapeutics than the European Medicines Authority and Health Canada and that the vast majority of the novel therapeutics first received approval for use in the United States.”
Rather than slow its pace since 2010, FDA has become even more aggressive in drug application approvals, he writes, particularly in the area of life-saving medications.
LaMattina also argues that Cruz’ bill would not mitigate the problem of drug shortages. “These shortages are very real and involve dozens of important medications (painkillers, cancer treatments, anesthetics),” he writes. “These tend to be low-profit drugs that few manufacturers are willing to produce. This has nothing to do with medical innovation. Rather, it involves ensuring that supplies can be available. Cruz can help FDA solve this problem by getting Congress to increase the agency’s funding so that more resources can be committed to approving new generic drug manufacturers both in the U.S. and abroad. Adding resources can also put downward pressure on prices as such a move would allow FDA to work through its backlog of generic drug applications.”